{"id":31,"date":"2026-08-31T11:32:42","date_gmt":"2026-08-31T11:32:42","guid":{"rendered":"https:\/\/e2ecomplianceadvisors.com\/blogs\/?p=31"},"modified":"2026-08-31T11:43:42","modified_gmt":"2026-08-31T11:43:42","slug":"md-13-test-license-for-medical-devices-in-india-full-guide","status":"publish","type":"post","link":"https:\/\/e2ecomplianceadvisors.com\/blogs\/md-13-test-license-for-medical-devices-in-india-full-guide\/","title":{"rendered":"MD-13 Test License for Medical Devices in India: Full Guide"},"content":{"rendered":"

If you’re a medical device manufacturer in India looking to manufacture devices specifically for testing, evaluation, or clinical investigation \u2014 and not for commercial sale \u2014 the MD-13 Test License<\/strong><\/a> for Medical Devices is the specific regulatory approval you need. It’s a distinct license category under the Medical Devices Rules 2017, and it’s one that gets overlooked until a product development team hits a compliance wall mid-project.<\/span><\/p>\n

The CDSCO MD-13 Test Licence allows manufacturers to produce limited quantities of medical devices for the purpose of testing, clinical investigation, or evaluation. Without it, manufacturing a medical device \u2014 even a prototype intended purely for trials \u2014 is a regulatory violation under Indian law.<\/span><\/p>\n

E2E Compliance Advisors assists medical device manufacturers across India with CDSCO licensing, including MD-13 applications, documentation, and regulatory compliance across device classes. This guide covers everything manufacturers need to know before applying.<\/span><\/p>\n

What Is an MD-13 Test License?<\/b><\/h2>\n

The MD-13 Test License for Medical Devices is a manufacturing license issued by CDSCO (Central Drugs Standard Control Organisation) that permits a manufacturer to produce medical devices exclusively for testing, evaluation, or clinical investigation \u2014 not for commercial distribution.<\/span><\/p>\n

It derives from Form MD-13 under the Medical Devices Rules 2017 and is governed by the same regulatory framework that covers all medical device manufacturing in India. The key distinction from a standard manufacturing license is purpose: MD-13 is exclusively for non-commercial production in controlled quantities.<\/span><\/p>\n

Who Needs an MD-13 Test License?<\/b><\/h2>\n

Any entity that manufactures a medical device in India for the following purposes needs a CDSCO MD-13 Test Licence:<\/span><\/p>\n

Clinical investigation<\/b> \u2014 producing devices for clinical trials before regulatory approval for commercial sale.<\/span><\/p>\n

<\/b><\/b><\/b><\/b>Performance evaluation<\/b> \u2014 manufacturing devices to be tested against performance benchmarks as part of the development process.<\/span><\/p>\n

<\/b><\/b>Safety and efficacy testing<\/b> \u2014 producing batches for internal or third-party testing as part of a pre-market evaluation program.<\/span><\/p>\n

<\/b><\/b><\/b><\/b>Export for evaluation<\/b> \u2014 manufacturing devices that will be sent abroad for testing purposes.<\/span><\/p>\n

Research institutions, startups in device development, and established manufacturers developing new product lines all fall within the scope of who needs this license. If a device is physically manufactured in India and intended for any form of testing before commercial approval, the MD-13 Test License for Medical Devices applies.<\/span><\/p>\n

What Can You Do With an MD-13 License?<\/b><\/h2>\n

The CDSCO Test License for Medical Devices authorises the licensee to:<\/span><\/p>\n